DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 26, 2026, has been entered.
Response to Arguments
Applicant’s has limited the claims to administering elobixibat to treat a specified renal or liver disease. Applicant alleges unexpected results as the subcutaneous administration yields a much higher bioavailability than the subcutaneous administration.
The examiner responds to Applicant’s arguments and allegations of unexpected results, below.
The examiner cites: Chedid et al., “Drug Profile Elobixibat for the Treatment of Constipation,” Expert Rev Gastroenterol Hepatol. 2018 Sep 20;12(10):951–960. Chedid explains that after oral administration elobixibat there is minimal exposure, and systemically available drug is highly protein bound (>99.5%). “There was no accumulation of elobixibat or associated metabolites within the plasma or urine.” In fact, after oral administration, elobixibat is present in “picomolar concentrations in plasma.” Despite this, elobixibat decreased plasma levels of LDL cholesterol in a dose-dependent manner. In view of the exceptionally low plasma and urine levels of the claimed API after oral administration, it is difficult to established an unexpectedly higher bioavailability of a the same drug when administered subcutaneously. Not only is a SQ administration known to be substantially more bioavailable as established in the Final Office Action dated March 31, 2026. In addition to those generic teachings, Chedid provides drug specific teachings and PK data showing that elobixibat is particularly less bioavailable orally.
Jaecklin teaches elobixibat for treating cholestasis. See prior art claim 6. Subcutaneous administration is listed among a limited listing of routes of administration. See par. 122.
The claimed agent is taught to treat claimed conditions. It is also taught to be able to be administered orally and subcutaneously among a limited list of routes of administration. The state of the art recognizes the lack of oral systemic absorption for oral drugs generically and more specifically an even less oral absorption for elobixibat as they are intended to work in the colon, e.g. It is not clear how a higher absorption after subcutaneous administration is an unexpected result when the systemic exposure after oral administration is almost non-existent. Moreover, Chedid also calls into question the practicality of Applicant’s showing as plasma concentration did not alter elobixibat’s ability to decrease plasma levels of LDL cholesterol in a dose-dependent manner.
With respect to the traversal of DP rejections,
The provisional rejection over 18/535,313 is also maintained in view of Jaecklin as the claims are directed to treating any renal disease or bile acid dependent disorder with an ASBT inhibitor. The examiner acknowledges that this application is the earlier filed application. As required by MPEP 804, “If a provisional double patenting rejection (statutory or nonstatutory) is the only rejection remaining in the earlier filed of the two conflicting design applications, the examiner should withdraw that rejection and permit that application to issue as a patent.”
At this stage, this is not the only remaining rejection and it is being maintained.
Status of the Claims
Claims 32-34, 36, 38-45, and 48-64 are pending. Claims 36, 38, 40-45, 48-52 are withdrawn. Claims 32-34, 39, and 53-64 are examined.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 32-34, 39, and 53-64 are rejected under 35 U.S.C. 103 as being unpatentable over Jaecklin et al., (US20220160726)(filed February 12, 2020), in view of Chedid et al., “Drug Profile Elobixibat for the Treatment of Constipation,” Expert Rev Gastroenterol Hepatol. 2018 Sep 20;12(10):951–960.
Jaecklin teaches treating cholestasis by administering an ASBT inhibitor at a dosage of at least 10 micrograms/kg/day. See Abstract. The ABSTI inhibitor can be elobixibat or a salt thereof, among a limited list of agents. See par. 7. The route of administration includes parenteral injection, including subcutaneous. See par.’s 122, 558, and 607. In some embodiments, a formulation can be for non-systemic delivery if administered orally. See par. 603. Such non-systemic means less than 5%, e.g., is administered systemically. See par. 132. Formulations are designed for less than 10% systemic delivery. See par. 133. A single dose can be delivered every 24 hours, e.g. This is interpreted as once daily. See par. 563. A reduction is symptoms includes a reduction in serum bile acid concentration. See par. 11. Liver enzyme ALT can be shown to decrease relative to baseline. See prior art claim 45, e.g. Bilirubin, ALT, and serum bile acid was shown in clinical study. See par. 744. Levels of ALT, AST, and bilirubin concentrations normalized over time. See par. 744. Administration can be for at least 4 weeks. See par. 579.
Chedid is cited below merely to provide expected PK data when administered orally.
Chedid explains that after oral administration elobixibat there is minimal exposure, and systemically available drug is highly protein bound (>99.5%). “There was no accumulation of elobixibat or associated metabolites within the plasma or urine.” In fact, after oral administration, elobixibat is present in “picomolar concentrations in plasma.” Despite this, elobixibat decreased plasma levels of LDL cholesterol in a dose-dependent manner.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claims 54-64, the claims are directed to a result of the claimed agent being administered by the claimed route of administration to a claimed subject population. Absent evidence to the contrary and limitations in the claims that distinguish, these descriptions are considered results of a step of administration that has been positively recited and a product of an optimized administration of a claimed agent. According to M.P.E.P. § 2111.04, “a ‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
The examiner notes that there do not appear to be additional limitations other than those claimed in the claims from which claims 54-64 depend as the Specification provides examples in which elobixibat was administered to mice.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of Jaecklin and Chedid. Chedid is cited merely to provide expected PK data and trends for the claimed API when administered orally. One would be motivated to do so because Jaecklin teaches administering the claimed agent to the claimed subject through the claimed route of administration for the claimed time period. The API is a known result-effective variable that can be optimized through nothing more than routine experimentation. Even further, the same biomarkers were taught to be evaluated, which would further aid in optimization. As such, there is a reasonable and predictable expectation of success in arriving at the claimed methods in view of Jaecklin.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 32-34, 39, and 53-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-25 of copending Application No. 18/535,313. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘313 application are directed to treating a renal disorder by administering an ASBT inhibitor, including elobixibat. The route of administration is broad and includes subcutaneous administration (see claim 9). The results of administration are claimed in both the instant application and the ‘313 application. As such, it would be obvious to arrive at the instant claims in view of the claims of the ‘313 application and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
As such, no claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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